K875135 is an FDA 510(k) clearance for the EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL. This device is classified as a Calibrators, Drug Specific (Class II - Special Controls, product code DLJ).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on April 5, 1988, 113 days after receiving the submission on December 14, 1987.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K875135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1987 |
| Decision Date | April 05, 1988 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DLJ — Calibrators, Drug Specific |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |